MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-12-21 for FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN) N/A 5678200 manufactured by Bard Access Systems.
[131176387]
The device has not been returned, at this time, to the manufacturer for evaluation. A lot history review (lhr) of recu0723 showed one other similar product complaint(s) from this lot number. The complaints for this lot number (recu0723) have been reported from the same facility in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[131176388]
It was reported that an air/bubble was found during aspiration. No other information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2018-03660 |
| MDR Report Key | 8189328 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-12-21 |
| Date of Report | 2019-01-25 |
| Date of Event | 2018-11-21 |
| Date Mfgr Received | 2019-01-23 |
| Device Manufacturer Date | 2018-07-01 |
| Date Added to Maude | 2018-12-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KELSEY ERICKSON |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225937 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. -9617592 |
| Manufacturer Street | BLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN) |
| Generic Name | CATHETER, SUBCLAVIAN |
| Product Code | LFJ |
| Date Received | 2018-12-21 |
| Returned To Mfg | 2019-01-02 |
| Model Number | N/A |
| Catalog Number | 5678200 |
| Lot Number | RECU0723 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-21 |